Dose of remifentanil for cardiac scans under anaesthesia in children.
Research type
Research Study
Full title
Study to evaluate the optimal dose of remifentanil infusion(effective dose in 80% of patients) required to ensure apnoea (of 30 seconds duration) during magnetic resonance imaging of the heart under general anaesthesia in children aged 1 to 6 years.
IRAS ID
146613
Contact name
Philip Arnold
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Eudract number
2014-004346-10
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
The management of children with heart disease depends upon accurate imaging. Young children require general anaesthesia during magnetic resonance (MR) scans. Movement of the child’s chest during acquisition of images will make interpretation of scans impossible. During general anaesthesia breathing is often controlled using a mechanical device (a ventilator). If this is combined with use of potent drugs (such as remifentanil), which suppress the child’s own breathing, it is possible to halt respiration for short periods. By keeping these ‘breath holds’ short and by monitoring the child this can be performed without risk. The optimal dose of remifentanil in this situation is uncertain.
Patients scheduled to undergo MR scans of their heart under general anaesthesia, at Alder Hey Hospital and aged from 1 year to 6 years will be recruited for the study. An infusion of remifentanil will be administered during the scan. If there is no evidence of breathing, during a standardised breath hold, this will be considered a success. The dose given to subsequent patients will depend on the response of all earlier patients and will be an estimate of the dose which will be successful in 80% of patients. This estimate will be taken from a statistical model, which also takes into account our current knowledge of dosing. Further measures will protect the patient: the patient will be cared for by a consultant anaesthetist; the patients will be monitored closely; it will not be possible to give a dose outside of that currently used in clinical practice and a panel of independent experts will review any adverse events.
Following the breath hold, management will be at the discretion of the clinical team. All observations, related to the study, will be complete shortly after the end of the anaesthetic.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0093
Date of REC Opinion
15 Apr 2015
REC opinion
Further Information Favourable Opinion